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Placebos and Principles: A Trial of Ondansetron

Marc L. Citron, MD
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Long Island Jewish Medical Center, New Hyde Park, NY 11042. Requests for Reprints: Marc L. Citron, MD, Division of Hematology/Oncology, Long Island Jewish Medical Center, New Hyde Park, NY 11042.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1993;118(6):470-471. doi:10.7326/0003-4819-118-6-199303150-00013
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Special ethical concerns exist about the use of placebo controls. A placebo-controlled study must answer four questions: [1] Was any therapeutic intervention available that could be reasonably assumed to be less harmful than the placebo control? [2] Did the placebo control pose more than minimal risk to those patients? [3] Was the study designed in every way possible to minimize potential harm to the patients receiving placebo? [4] Were the patients fully and accurately informed of the additional risk of being in the placebo group?

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